Beijing Defengrui Biological Technology Co. Ltd.

Primary objective: To evaluate the efficacy of multiple doses of BDB-001 injection as an alternative to glucocorticoids in the treatment of ANCA-associated vasculitis. Secondary objectives: 1) To evaluate the safety and tolerability of multiple doses of BDB-001 injection as an alternative to glucocorticoids in patients with ANCA-associated vasculitis; 2) To evaluate the pharmacokinetic and pharmacodynamic characteristics of BDB-001 injection as an alternative to glucocorticoids in patients with ANCA-associated vasculitis, and to provide a reference for the dosing regimen of confirmatory clinical trials. Exploratory objectives: If data permit, to evaluate the relationship between the exposure of BDB-001 injection as an alternative to glucocorticoids in patients with ANCA-associated vasculitis and the efficacy and adverse events, as well as the relationship between pharmacodynamic indicators and efficacy and adverse events.

Primary objective: To explore the efficacy of multiple administrations of BDB-001 injection in the treatment of moderate to severe hidradenitis suppurativa. Secondary objective: To evaluate the safety of BDB-001 injection in the long-term treatment of moderate to severe hidradenitis suppurativa. Exploratory objective: To explore the changes in cytokines and lymphocyte typing in the treatment of moderate to severe hidradenitis suppurativa with BDB-001 injection.

Main objectives: 1) To evaluate the safety and tolerability of multiple administrations of BDB-001 injection in patients with moderate to severe hidradenitis suppurativa; 2) To evaluate the pharmacokinetic and pharmacodynamic characteristics of BDB-001 injection in patients with moderate to severe hidradenitis suppurativa, and to provide a reference for the dosing regimen of confirmatory clinical trials. Secondary objectives: To preliminarily explore the efficacy of multiple administrations of BDB-001 injection in the treatment of moderate to severe hidradenitis suppurativa. Exploratory objectives: To preliminarily explore the changes in cytokines and lymphocyte typing in the treatment of moderate to severe hidradenitis suppurativa with BDB-001 injection.